Acupuncture Treatment for Schizophrenia-related Central Obesity

Schizophrenia Clinical Trial

Official title:

Study on the Optimal Scheme of Acupuncture Treatment for Schizophrenia-related Central Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833009
• Other study ID #: 2022-64
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2023
• Source: Shanghai Mental Health Center
• Contact: Jianhua Chen
• Phone: (+86) 18017311011
• Email: jianhua.chen[@]smhc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial aims to test the effect of acupuncture in patients with schizophrenia-related central obesity. The main question it aims to answer is: • The effect, safety, and maintenance of acupuncture on schizophrenia-related central obesity. Participants will receive acupuncture treatment on purpose acupoints, acupuncture on acupoint peripheries, or fake acupuncture treatment on purpose acupoints for 20 weeks. And they need three follow-up visits during the treatment period and two follow-up visits after treatment. Researchers will compare the waist circumstance of these three groups to see if the purpose acupoints are valid for schizophrenia-related central obesity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders:

Fifth Edition);

• Continuous use of antipsychotics for more than one year (may be combined with mood stabilizers, antianxiety medications, antidepressants, and benzodiazepines);
• Abdominal obesity (central obesity): waist circumference =90cm for men or =85cm for women (Chinese Standard);
• All participants and their guardians signed informed consent.

Exclusion Criteria:

• Had various traditional Chinese medicine or chemical drugs, or acupuncture treatments for central obesity within two weeks before enrollment;
• Pregnant or lactating woman;
• Organic mental disorders and mental disorders induced by psychoactive and non-addictive substances;
• With other diseases affecting their mental state (e.g., chronic obstructive pulmonary disease, coronary heart disease, angina pectoris, stroke, painful joint diseases, severe psychiatric diseases, tumors, and other physical diseases)
• Severe liver and kidney insufficiency or other serious diseases of the system;
• With a family history of metabolic diseases such as hypertension, diabetes, and hyperlipidemia;
• Acupuncture dizziness, needle phobia, and other intolerant acupuncture treatment;
• Patients who are not treated according to the regulations, cannot determine the efficacy or have incomplete data affecting the efficacy and safety evaluation.

Related Conditions & MeSH terms

• Central Obesity
• Obesity
• Obesity, Abdominal
• Schizophrenia

Intervention

Device:
• Acupuncture
All the groups receive respective treatment 3 times a week for the first eight weeks, twice a week for another 8 weeks, and once a week for the last 4 weeks.

Locations

Country	Name	City	State
China	Shanghai Huangpu Mental Health Center	Shanghai	Shanghai
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Shanghai Huangpu Mental Health Center, Shanghai University of Traditional Chinese Medicine, Yueyang Hospital of lntegrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Waist Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively	Waist Circumference in centimiter	Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Secondary	Change from Baseline Body Weight Index at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively	weight and height will be combined to report BMI in kg/m^2	Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Secondary	Change from Baseline Hip Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively	Hip Circumference in centimiter	Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Secondary	Change from Baseline both Blood Pressure at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively	both Blood Pressure in mm/Hg	Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Secondary	Change from Baseline Blood Triglyceride at 16 weeks, 32 weeks, respectively	Blood Triglyceride in mmol/L	Baseline, 16 weeks, 32 weeks
Secondary	Change from Baseline Blood Total Cholesterol at 16 weeks, 32 weeks, respectively	Total Cholesterol in mmol/L	Baseline, 16 weeks, 32 weeks
Secondary	Change from Baseline Blood Low-density Lipoprotein at 16 weeks, 32 weeks, respectively	Blood Low-density Lipoprotein in mmol/L	Baseline, 16 weeks, 32 weeks
Secondary	Change from Baseline Blood High-density Lipoprotein at 16 weeks, 32 weeks, respectively	Blood High-density Lipoprotein in mmol/L	Baseline, 16 weeks, 32 weeks
Secondary	Change from Baseline Blood Glucose at 16 weeks, 32 weeks, respectively	Blood Glucose in mmol/L	Baseline, 16 weeks, 32 weeks
Secondary	Change from Baseline Positive And Negative Syndrome Scale at 8 weeks, 20 weeks, 32 weeks, respectively	The Positive And Negative Syndrome Scale is used for valuation of positive symptom, negative symptom and general symptom of patients with schizophrenia. The score range of Positive And Negative Syndrome Scale is 0 to 150. The higher the score, the more severe the psychiatric symptoms.	Baseline, 8 weeks, 20 weeks, 32 weeks
Secondary	Change from Baseline Clinical Global Impression at 8 weeks, 20 weeks, 32 weeks, respectively	The Clinical Global Impression evaluates the severity of ilness, global improvement and efficacy index. The score range of severity of ilness is 0 (none) to 7 (extremly severe). The score range of global improvement is 0 (none) to 7 (seriously deteriorated). The score range of efficacy index is 0 (none) to 4 (effective and no adverse effect).	Baseline, 8 weeks, 20 weeks, 32 weeks
Secondary	Change from Baseline Personal and Social Performance Scale at 8 weeks, 20 weeks, 32 weeks, respectively	The score range of Personal and Social Performance Scale is 1 to 100. The higher score, the better personal and social performance.	Baseline, 8 weeks, 20 weeks, 32 weeks
Secondary	Change from Baseline Appetite visual analogue scale at 8 weeks, 20 weeks, 32 weeks, respectively	The score range of Appetite visual analogue scale is 0 to 10. The higher score, the better appetite.	Baseline, 8 weeks, 20 weeks, 32 weeks
Secondary	Change from Baseline Treatment Emergent Symptom Scale at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively	The Treatment Emergent Symptom Scale contains 34 different common adverse effects in psychiatry patients. Each adverse effect can be assessed from three aspects, which are serverity, relationship with medications, and mesurement taken. The score range of serverity is 0 (none) to (servere). The range of relationship with medication is none, basicly (likelihood 10%) , maybe (likelihood 10%-50%), very likely (likelihood 50%-80%), definitely (likelihood over 90%). The score range of measurement taken is 0 (none) to 5 (stop medication).	Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks